AADT1D: Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04789993

Collaborator

(none)

250

Enrollment

Location

1.5

Anticipated Duration (Months)

165.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Autoimmune Diseases Hashimoto Disease Graves Disease Celiac Disease Addison Disease Vitiligo	Other: No intervention.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Additional Autoimmune Diseases With Type 1 Diabetes in Children and Adolescents at Diabetes Diagnostic and During Follow-up : a Monocentric Study in France

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Outcome Measures

Primary Outcome Measures

Number of additional autoimmune diseases at type 1 diabetes diagnosis [up to 3 weeks after type 1 diabetes diagnosis]
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Type of additional autoimmune diseases at type 1 diabetes diagnosis [up to 3 weeks after type 1 diabetes diagnosis]
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations

Secondary Outcome Measures

Characteristics of patients, if additional autoimmune disease is present or absent [up to 3 weeks after type 1 diabetes diagnosis]
Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Occurence or non-occurence of at least one additional autoimmune diseases during follow-up [From type 1 diabetes diagnostic to last news date, an average of 3 years]
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations
Occurence or non-occurence of each type of additional autoimmune disease during follow-up [From type 1 diabetes diagnostic to last news date, an average of 3 years]
Will be studied the additional autoimmune diseases to type 1 diabetes listed in the 2018 ISPAD recommendations, in this outcome studied each one separately
Presence of antibodies specific to an additional autoimmune disease at type 1 diabetes diagnostic [up to 3 weeks after type 1 diabetes diagnosis]
Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Characteristics of patients, if at least one type of antibodies specific to an autoimmune disease is present or absent at type 1 diabetes diagnostic [up to 3 weeks after type 1 diabetes diagnosis]
Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Characteristics of patients, for each type of antibodies specific to an autoimmune disease, present or absent at type 1 diabetes diagnostic [up to 3 weeks after type 1 diabetes diagnosis]
Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic
Occurence or non-occurence of at least one type of antibody specific to an additional autoimmune disease [From type 1 diabetes diagnosis to last news date, from 1 to 6 years]
Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Occurence or non-occurence of antibodies specific to each additional autoimmune disease listed in outcome 5 [From type 1 diabetes diagnosis to last news date, from 1 to 6 years]
Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
Description of the characteristics of all the patients followed in our cohort of pediatric type 1 diabetes [Up to 3 weeks after type 1 diabetes diagnosis]
Family and personal history, biological, serological, anthropometrical characteristics at type 1 diabetes diagnostic, presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases
Description of the autoimmune characteristics of all the patients followed in our cohort of pediatric type 1 diabetes [during follow-up : From type 1 diabetes diagnosis to last news date, from 1 to 6 years]
presence of antibodies specific to an additional autoimmune disease, and occurence of additional autoimmune diseases
If detection of antibodies specific to an additional autoimmune disease : delay between detection of these antibodies and diagnosis of the corresponding autoimmune disease [From type 1 diabetes diagnosis to last news date, from 1 to 6 years]
Antibodies detected in the serum, antibodies specific to the following autoimmune diseases : Hashimoto (Thyroid peroxidase antibodies, and/or thyroglobulin antibodies) Graves disease (TRAK), coeliac disease (anti-tissue transglutaminase (tTG) antibodies,endomysial antibodies (EMA)), Addison disease ( adrenal antibodies ), autoimmune gastritis (parietal cell antibodies)
If patient diagnosed with Hashimoto when type 1 diabetes is diagnosed, proportion of patients with thyroid dysfunction [Up to 3 weeks after type 1 diabetes diagnosis]
Thyroid dysfunction : hormonal dysfunction associated to Hashimoto
Occurence of thyroid dysfunction in patients with type 1 diabetes and Hashimoto [From type 1 diabetes diagnosis to last news date, from 1 to 6 years]
Occurence during type 1 diabetes follow-up of thyroid dysfunction in patients with Hashimoto
Proportion of patients with thyroid dysfunction due to Hashimoto needing a specific treatment [Up to 3 weeks after type 1 diabetes diagnosis]
Occurence of specific treatment onset in patients followed for type 1 diabetes with thyroid dysfunction due to Hashimoto [From type 1 diabetes diagnosis to last news date, from 1 to 6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with type 1 diabetes diagnosed with the following criteria: (i) Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dl), or (ii) fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl) ; and (iii) presence of diabetes associated autoantibodies : ICA, GAD, IA2, IAA and/or ZnT8
age < 18 years old at type 1 diabetes diagnostic
type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01